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The role: CSV Specialist - Freelancer
We are seeking an expert in verification or validation of software or systems for a medical device producer of surgical instruments that are used in endoscopic procedures and minimally invasive surgery. The position is based in Bavaria and is a 6 month contract with the possibility of an extension.
Responsibilities as CSV Specialist
-Categorize existing software as not subject to validation
-Assessment of cases that may require validation
-Risk assessment for new purchases
-Formal and substantive review of specifications, architectural descriptions, module, and detailed design descriptions, test plans, specifications and reports
-Creation of documents of the system life cycle, such as validation/qualification plans, requirement specifications, risk analysis, test plans, etc.
-Process creation and company-wide implementation
-Training and instruction of the departments
-Further development and maintenance of the systems for documentation of software validation
-Perform validations
Skills and Experience Required as CSV Specialist
-Completed studies in the fields of computer science, electrical engineering or natural sciences
-Project management skills
-Fluent in German and very good knowledge of English
-Experience in validation and with CSV projects within the medical device industry.
- GAMP5 experience
-Basic knowledge of the SAP environment
How to apply
Apply here if you are interested in this opportunity please apply on the link below or if you would like a confidential discussion about your career opportunities please contact Liam Tennant of EPM Scientific.
Disclaimers if necessary: Must have the rights to Work in Germany
Computer System Validation Freelancer (CSV)
We are seeking an expert in verification or validation of software or systems for a medical device producer of surgical instruments that are used in endoscopic procedures and minimally invasive surgery. The position is based in Bavaria and is a 6 month contract with the possibility of an extension.
Responsibilities as CSV Specialist
-Categorize existing software as not subject to validation
-Assessment of cases that may require validation
-Risk assessment for new purchases
-Formal and substantive review of specifications, architectural descriptions, module, and detailed design descriptions, test plans, specifications and reports
-Creation of documents of the system life cycle, such as validation/qualification plans, requirement specifications, risk analysis, test plans, etc.
-Process creation and company-wide implementation
-Training and instruction of the departments
-Further development and maintenance of the systems for documentation of software validation
-Perform validations
Skills and Experience Required as CSV Specialist
-Completed studies in the fields of computer science, electrical engineering or natural sciences
-Project management skills
-Fluent in German and very good knowledge of English
-Experience in validation and with CSV projects within the medical device industry.
- GAMP5 experience
-Basic knowledge of the SAP environment
How to apply
Apply here if you are interested in this opportunity please apply on the link below or if you would like a confidential discussion about your career opportunities please contact Liam Tennant of EPM Scientific.
Disclaimers if necessary: Must have the rights to Work in Germany